"The benefits of antidepressants is based upon just one probability, one which has been debunked as non-scientific by many academics. The risks of taking antidepressants are reported side effects, including self-harm, suicidal thoughts and suicide completion. And we are **still** told by Dr's, pharmaceutical companies and medicine regulators that the benefits outweigh the risks. This is an incorrect statement.."

Monsanto Roundup Lawsuit

Wednesday, January 13, 2016

GlaxoSmithKline: No Smoke Without Fire - Witty Implicated

I love stumbling on court documents, especially when those documents are complaints against British pharmaceutical giant, GlaxoSmithKline.

GlaxoSmithKline made claims that they were going to be more transparent after the Department of Justice handed down a record breaking $3 billion fine to them back in 2012.

Cynics, such as me, didn't believe them. Looks like this old cynic has been proven right.

Former GlaxoSmithKline biostatistics manager, Alexandre Selmani, has filed a whistleblower lawsuit in a New Jersey state court. The complaint alleges that GSK fired Selmani for alleging dishonest study data was used to promote the effectiveness of a smoking-cessation product, NiQuitin.

The complaint alleges that GSK engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment.

In 2012, Seimani discovered that there were numerous mistakes made in the "Smokers Health Project" being conducted by Defendant Kotler, Selmani's direct supervisor and a Director of Biostatistics, at Defendant GSK , specifically the mistakes involved with the Phantom Patch study 53820642 and the Nicotine Film study RH01589, which affected the projects quality.

As early as the spring of 2012 Selmani brought the mistakes to the attention of Defendant Kotler and demonstrated to Defendant Kotler that his mistakes rendered the results of the project to be unreliable.

In mid-December of 2012, having had no success with Defendant Kotler, Selmani advised the company's then vice president Howard Marsh (hereinafter "Marsh',) via e-mail, that mistakes were being made in the "Smokers Health Project", specifically Selmani showed Marsh that the study on the Phantom Patch 53820642 had numerous mistakes in the statistical methodology which affected the quality of the results. These studies had been conducted by Defendant Kotler.

Within fifteen minutes of Selmani sending the e-mail to Marsh, Marsh responded to Selmani via e-mail which stated: "Whilst it is important to create a culture of technical debate and challenge, it is vital that we do this in a professional manner. I appreciate that sometimes on email the tone of your intent may be misconstrued". Still nothing was done to correct the mistakes.

On February 18, 2013, Selmani again brought the mistakes in the studies 53820642 and RH01589, to the attention of Defendant Witty, the CEO of the company, specifically, by sending an email advising him of the mistakes in some of the CH clinical studies which had the capacity to cause negative consequences and potential health and safety issues for the general public. In the e-mail, Selmani reported that his current manager, Defendant Kotler, refused to make corrections to the errors in the clinical studies as set forth supra. The errors related to the studies were outlined in the a-mail. They were ignored and the studies were made public on April 8, 2014 in the Journal of Psychopharmacology.

Selmani sent out various other emails voicing his concerns over the discrepancies, one in July 2013 to James Ford VP Counsel as well as Kenneth James, Head of Research and Development. Furthermore, On June 2, 2014, Selmani sent an e-mail to Defendant Emma Walmsley the company's CEO GSK CH (London, UK). Following this email Selmani was told by Human Resources that he should no longer report to Kotler, however, he was not given another manager to report to.

After 9 months, it appears GSK had a change of heart and told Selmani that he could report to Kotler once again. Unfortunately, for Selmani, it was Kotler who was authorized to conduct his performance review.

No prizes for guessing what happened next folks.

Selmani received low performance scores and was eventually terminated from his employment with GSK on October 17, 2015.

More from the complaint...

Selmani seeks compensatory and punitive damages, attorneys' fees, costs, and such other relief as the Court deems equitable and just.

At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly were deliberate co-conspirators of the aforesaid fraudulent and/or illegal activity.

At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly knew or should have reasonably known of the aforesaid fraudulent and/or illegal activity.

At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly had a duty to properly investigate and/or address the aforesaid fraudulent and/or illegal activity.

At all times relevant hereto, Defendants Kotler, Witty, Kennedy, and Walmsly, by and through their knowledge of and/or complicity with the aforesaid fraudulent and/or illegal activity, aided and/or abetted the same.